This is a multicenter, dose-ranging study including adult male and female subjects (>= 18 years old) with symptomatic Oral Lichen Planus (OLP). A total of approximately 24 subjects will be enrolled at approximately eight (8) study sites in the United States. This study will evaluate the safety, tolerability and efficacy of LP-10 at 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus.The study consists of screening, treatment and follow-up phases. The treatment phase includes 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks. The follow-up phase includes one post-treatment visit 2 weeks after the last oral LP-10 dose.

开始日期2024-07-01

申办/合作机构

Lipella Pharmaceuticals, Inc.

NCT03129126

/ Completed临床2期

A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis

The purpose of this study is to assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). Twelve subjects meeting the inclusion and exclusion criteria will be enrolled and treated in a prospective and multi-center trial with LP-10. The proposed trial will recruit 12 subjects in a dose-escalation trial where 4 subjects will be allocated into each one of three groups.

开始日期2020-10-01

申办/合作机构

Lipella Pharmaceuticals, Inc.

DRKS00009364

/ CompletedN/A

The course of therapy, safety and pharmacokinetic parameters of conversion of Prograf® to Tacrolimus Hexal®/Crilomus® in renal transplant recipients – an observational study in Germany

开始日期2014-08-11

申办/合作机构

Hexal AG

100 项与他克莫司脂质体相关的临床结果

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100 项与他克莫司脂质体相关的转化医学

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100 项与他克莫司脂质体相关的专利（医药）

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14,747

项与他克莫司脂质体相关的文献（医药）

2026-08-01·ANNALS OF PHARMACOTHERAPY

Comment: Olanzapine Versus Quetiapine: Corrected QT Changes in Critically Ill Patients

作者: DeGrado, Jeremy R. ; Shen, Kaden ; Dube, Kevin M. ; Szumita, Paul M. ; Lupi, Kenneth E.

Background:: Olanzapine and quetiapine are frequently administered atypical antipsychotic medications and their effects on the corrected QT (QTc) in the critically ill population remain understudied.Objective:: The objective of this study was to compare the impact of olanzapine and quetiapine on QTc changes in critically ill patients.Methods:: This was a single-center, retrospective anal.Adult patients admitted to the intensive care unit (ICU) from Jan. 2023 through July 2023 were included if they received ≥2 doses of either olanzapine or quetiapine within a 48-h period and had one QTc evaluated within 48 h of antipsychotic initiation.The major endpoint was a composite of the incidence of QTc prolongation (defined as QTc > 500 ms or QTc > 60 ms above baseline) following antipsychotic initiation.Univariable and multivariable analyses were performed to identify risk factors for QTc prolongation.Results:: There was no statistical difference in the major composite endpoint between patients in the olanzapine and quetiapine groups (8/83 [9.6%] vs 19/129 [14.7%]; P = .28).The incidence of QTc > 500 ms (7/244 [2.9%] vs 20/427 [4.7%]; P = .25) and change from baseline >60 ms (5/244 [2.0%] vs 17/427 [4.0%]; P = .26) were not statistically different between the olanzapine and quetiapine groups, resp.There were no occurrences of Torsades de Pointes or extrapyramidal symptoms in either group.Conclusion and Relevance:: The results of this study suggest olanzapine and quetiapine may have similar impact on QTc prolongation in critically ill patients.These findings could contribute to safer prescribing practices in the ICU.

2026-02-01·JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION

Impact of COVID-19 Omicron variant on lung transplantation patients with 1-year follow-up: A single tertiary medical center experience

Article

作者: Fang, Hsin-Yueh ; Hu, Han-Chung ; Kao, Kuo-Chin ; Leu, Shaw-Woei ; Chang, Ko-Wei ; Chen, Wei-Hsun

BACKGROUND:

Lung transplantation patients with coronavirus disease 2019 (COVID-19) have high mortality. However, the impact of the Omicron variant in lung transplantation patients is unclear. This study focuses on lung transplant patients diagnosed with COVID-19 during the Omicron wave, and investigate the clinical presentations, outcomes and pulmonary function.

METHODS:

In this single-center retrospective study, we enrolled lung transplantation patients diagnosed with COVID-19 from January 2022 to December 2022. Demographic, laboratory and pulmonary function data were recorded. Pre-COVID-19 pulmonary function data were obtained from the closest routine test, and post-COVID-19 tests were arranged after release from isolation.

RESULTS:

Of the 22 enrolled patients, four were admitted to general wards for treatment and observation, and two needed oxygen support. All of the patients recovered from COVID-19. There were no significant decreases in forced vital capacity (FVC) (2.3 ± 0.6 vs. 2.2 ± 0.8 L, p = 0.363) and forced expiratory volume in the first second (FEV1) (2.0 ± 0.6 vs. 1.9 ± 0.8 L, p = 0.269) after COVID-19 infection. Daily prednisolone dose and serum tacrolimus levels were significantly correlated to the duration of positive COVID-19 test and change in FEV1. Patients who did not receive a booster dose of COVID-19 vaccination had a significantly longer positive test duration (9.1 ± 4.1 vs. 26.6 ± 24.4 days, p = 0.05), and greater decrease in FEV1 (23.6 ± 137.3 vs. -331.8 ± 537.8 L, p = 0.040).

CONCLUSIONS:

In this study, lung transplant patients infected with COVID-19 during the Omicron wave had low rate of severe disease and mortality. Immunosuppressive medications and COVID-19 vaccination were correlated with viral clearance and pulmonary function after COVID-19 infection.

2026-01-01·Dermatology and Therapy

Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial

Article

作者: Herve Sroussi ; Jennifer Frustino ; Hirak B. Routh ; Alessandro Villa ; Jennifer L. Parish ; Sunil Dhawan ; Michael T. Brennan ; Michael B. Chancellor ; Gerald L. Klein ; Kamal Al-Eryani

INTRODUCTION:

Oral lichen planus (OLP) is a serious chronic inflammatory condition with malignant transformation potential affecting six million Americans which has no US Food and Drug Administration (FDA)-approved therapy. LP-10, a novel liposomal tacrolimus oral rinse, overcomes the poor adherence to oral surfaces and inconsistent drug delivery limitations of existing treatments.

METHODS:

This phase 2a multicenter dose-ranging study evaluated LP-10 safety and efficacy in symptomatic OLP. Twenty-seven adults (22 female, 5 male) received a 10-mL oral rinse of LP-10 at 0.25 mg, 0.5 mg, or 1.0 mg of tacrolimus, for 3 min twice daily for 4 weeks. Safety assessments included monitoring of adverse events, laboratory studies, and tacrolimus blood levels. Efficacy was measured by investigator global assessment (IGA), reticulation/erythema/ulceration (REU) score, pain/sensitivity numerical rating scale (NRS), OLP symptom severity measure (OLPSSM), and patient global response assessment (GRA).

RESULTS:

All participants completed treatment without discontinuation or serious adverse events. Treatment-related treatment-emergent adverse events were mild/moderate (50 mild, 4 moderate). LP-10 demonstrated exceptional pharmacokinetic safety with mean tacrolimus levels remaining < 1.0 ng/mL in 75% of post-baseline measurements; the maximum individual level (4.5 ng/mL) remained well below the toxicity threshold (15 ng/mL) suggesting little absorbance into the blood. All efficacy endpoints showed statistically significant and clinically meaningful improvements at week 4: mean and standard deviation (SD) values for IGA decreased from 3.5 ± 0.51 to 1.8 ± 1.37 (p < 0.0001), pain NRS from 6.8 ± 1.90 to 2.3 ± 2.53 (p < 0.0001), sensitivity NRS from 7.2 ± 1.71 to 2.9 ± 2.29, REU from 26.5 ± 10.4 to 13.2 ± 8.15 (p < 0.0001). Of the 23 participants who responded to the GRA, approximately 78% participants reported that their quality of life was "moderately better" or "very much better" as compared to when they started the study, across all doses. All prior corticosteroid failures (5/5) responded, with benefits sustained through 2-week follow-up.

CONCLUSIONS:

LP-10 demonstrated excellent safety with minimal systemic absorption and clinically meaningful efficacy, representing substantial improvement over existing therapies for this serious condition with significant unmet medical need. Larger controlled studies are warranted to confirm these promising findings.

CLINICAL TRIAL REGISTRATION:

NCT06233591.

项与他克莫司脂质体相关的新闻（医药）

2026-04-07

·药通社

2026，药企倒闭潮再次来袭！

3月31日消息，丹麦前沿肿瘤疫苗公司 IO Biotech 已停止运营，并遣散了员工、高管团队及董事会成员，正式申请破产。据了解，2025年9 月，IO Biotech拟提交治疗性癌症疫苗 Cylembio 的上市申请，遭到FDA驳回后，在当月其就已裁掉50%的员工。在该公司与 FDA 的后续沟通始终无果，其原定于 12 月举行的会议结果也并未对外披露后，该公司又考虑进一步削减人员，公司还聘请了财务顾问，寻求战略替代方案。无独有偶，Lipella Pharmaceuticals也在同日申请了破产。据悉该公司正在研发一款抗炎漱口水，用于治疗口腔扁平苔藓 —— 一种影响口腔黏膜的自身免疫性疾病。原本其计划将 LP-10 推进至 2b 期临床试验，最终目标是拿下 FDA 批准的全球首个口腔扁平苔藓(OLP)疗法。在此之前，专注分子胶技术研发的美国加州生物科技公司 f5 Therapeutics 也宣布了关停。作为专注于靶向蛋白降解技术的生物技术公司，其致力于利用其专有的NExMods™平台重塑药物发现过程，寻找和确定新的疾病靶点。在3月，还有专注为基因罕见病开发个性化疗法的生物科技公司EveryOne Medicines宣布关停。另外，美国生物技术公司Nido Biosciences也因治疗罕见神经系统疾病的在研小分子药物II期临床失败，在1月已宣布正式停止运营。除了以上企业，实际上在2025年，生物医药产业就已迎来Biotech 企业倒闭潮。根据《Fierce Biotech》等媒体的追踪统计，2025年在美国就至少22家Biotech企业正式停止运营或进入破产清算程序。从抗癌疫苗到分子胶技术，从罕见病药物到自身免疫病疗法等，不同赛道的Biotech 企业接连离场，已反映出当前行业正面临着严峻的生存挑战。从整体来看，大部分Biotech倒闭的原因，是资金链断裂和临床失败。而除此之外，还有部分企业则是错判了技术迭代的节奏。如由5位亿万富翁投资5亿美元的AI制药企业——Arena BioWorks，曾被寄予“颠覆药物发现”的厚望。然而，仅仅21个月后，它就因“宏观环境变化、政策不确定性”宣布关闭。业内分析认为，2026年开年以来Biotech倒闭潮的核心驱动因素可概括为“资本退潮、政策倒逼、技术兑现乏力”的三重叠加，而本质则是行业正从“资本催熟”向“价值驱动”深刻转型。未来，能实现差异化创新，拥有稳健的现金流、清晰的商业化路径，以及全球化能力的企业，才能在激烈的竞争中拥有一席之地，乃至保持行业优势。参考：制药网 ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

疫苗临床2期

2026-04-03

·搜狐新闻

药企倒闭潮再次来袭！

3月31日消息，丹麦前沿肿瘤疫苗公司 IO Biotech 已停止运营，并遣散了员工、高管团队及董事会成员，正式申请破产。据了解，2025年9 月，IO Biotech拟提交治疗性癌症疫苗 Cylembio 的上市申请，遭到FDA驳回后，在当月其就已裁掉50%的员工。在该公司与 FDA 的后续沟通始终无果，其原定于 12 月举行的会议结果也并未对外披露后，该公司又考虑进一步削减人员，公司还聘请了财务顾问，寻求战略替代方案。无独有偶，Lipella Pharmaceuticals也在同日申请了破产。据悉该公司正在研发一款抗炎漱口水，用于治疗口腔扁平苔藓 —— 一种影响口腔黏膜的自身免疫性疾病。原本其计划将 LP-10 推进至 2b 期临床试验，最终目标是拿下 FDA 批准的全球首个口腔扁平苔藓(OLP)疗法。在此之前，专注分子胶技术研发的美国加州生物科技公司 f5 Therapeutics 也宣布了关停。作为专注于靶向蛋白降解技术的生物技术公司，其致力于利用其专有的NExMods™平台重塑药物发现过程，寻找和确定新的疾病靶点。在3月，还有专注为基因罕见病开发个性化疗法的生物科技公司EveryOne Medicines宣布关停。另外，美国生物技术公司Nido Biosciences也因治疗罕见神经系统疾病的在研小分子药物II期临床失败，在1月已宣布正式停止运营。除了以上企业，实际上在2025年，生物医药产业就已迎来Biotech 企业倒闭潮。根据《Fierce Biotech》等媒体的追踪统计，2025年在美国就至少22家Biotech企业正式停止运营或进入破产清算程序。从抗癌疫苗到分子胶技术，从罕见病药物到自身免疫病疗法等，不同赛道的Biotech 企业接连离场，已反映出当前行业正面临着严峻的生存挑战。从整体来看，大部分Biotech倒闭的原因，是资金链断裂和临床失败。而除此之外，还有部分企业则是错判了技术迭代的节奏。如由5位亿万富翁投资5亿美元的AI制药企业——Arena BioWorks，曾被寄予“颠覆药物发现”的厚望。然而，仅仅21个月后，它就因“宏观环境变化、政策不确定性”宣布关闭。业内分析认为，2026年开年以来Biotech倒闭潮的核心驱动因素可概括为“资本退潮、政策倒逼、技术兑现乏力”的三重叠加，而本质则是行业正从“资本催熟”向“价值驱动”深刻转型。未来，能实现差异化创新，拥有稳健的现金流、清晰的商业化路径，以及全球化能力的企业，才能在激烈的竞争中拥有一席之地，乃至保持行业优势。免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。文章来源：制药网>更多精彩：· · · · · 返回搜狐，查看更多

2026-04-03

·制药网

倒闭潮来袭！2026 年医药行业 Biotech 密集出清

【制药网行业动态】3月31日消息，丹麦前沿肿瘤疫苗公司 IO Biotech 已停止运营，并遣散了员工、高管团队及董事会成员，正式申请破产。　　据了解，2025年9 月，IO Biotech拟提交治疗性癌症疫苗 Cylembio 的上市申请，遭到FDA驳回后，在当月其就已裁掉50%的员工。在该公司与 FDA 的后续沟通始终无果，其原定于 12 月举行的会议结果也并未对外披露后，该公司又考虑进一步削减人员，公司还聘请了财务顾问，寻求战略替代方案。　　无独有偶，Lipella Pharmaceuticals也在同日申请了破产。据悉该公司正在研发一款抗炎漱口水，用于治疗口腔扁平苔藓 —— 一种影响口腔黏膜的自身免疫性疾病。原本其计划将 LP-10 推进至 2b 期临床试验，最终目标是拿下 FDA 批准的全球首个口腔扁平苔藓(OLP)疗法。　　在此之前，专注分子胶技术研发的美国加州生物科技公司 f5 Therapeutics 也宣布了关停。作为专注于靶向蛋白降解技术的生物技术公司，其致力于利用其专有的NExMods™平台重塑药物发现过程，寻找和确定新的疾病靶点。　　在3月，还有专注为基因罕见病开发个性化疗法的生物科技公司EveryOne Medicines宣布关停。另外，美国生物技术公司Nido Biosciences也因治疗罕见神经系统疾病的在研小分子药物II期临床失败，在1月已宣布正式停止运营。　　除了以上企业，实际上在2025年，生物医药产业就已迎来Biotech 企业倒闭潮。根据《Fierce Biotech》等媒体的追踪统计，2025年在美国就至少22家Biotech企业正式停止运营或进入破产清算程序。　　从抗癌疫苗到分子胶技术，从罕见病药物到自身免疫病疗法等，不同赛道的Biotech 企业接连离场，已反映出当前行业正面临着严峻的生存挑战。　　从整体来看，大部分Biotech倒闭的原因，是资金链断裂和临床失败。而除此之外，还有部分企业则是错判了技术迭代的节奏。如由5位亿万富翁投资5亿美元的AI制药企业——Arena BioWorks，曾被寄予“颠覆药物发现”的厚望。然而，仅仅21个月后，它就因“宏观环境变化、政策不确定性”宣布关闭。　　业内分析认为，2026年开年以来Biotech倒闭潮的核心驱动因素可概括为“资本退潮、政策倒逼、技术兑现乏力”的三重叠加，而本质则是行业正从“资本催熟”向“价值驱动”深刻转型。未来，能实现差异化创新，拥有稳健的现金流、清晰的商业化路径，以及全球化能力的企业，才能在激烈的竞争中拥有一席之地，乃至保持行业优势。　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。

疫苗临床2期

100 项与他克莫司脂质体相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
口腔扁平苔藓	临床2期	美国	Lipella Pharmaceuticals, Inc.	2024-07-01
出血性膀胱炎	临床2期	美国	Lipella Pharmaceuticals, Inc.	2020-10-01
移植物抗宿主病	临床1期	美国	Lipella Pharmaceuticals, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06233591 (GlobeNewswire) 人工标引	临床2期	口腔扁平苔藓	-	LP-310 (Second Cohort)	齋繭醖壓憲夢構廠觸鹽(糧築製鏇鏇膚遞齋選選) = Improved from 3.42 ± 0.21 at baseline to 2.71 ± 0.30 at week 1 (p=0.029), 1.71 ± 0.43 at week 4 (p=0.007) and 2.75 ± 0.34 at week 6 (p=0.112). 鬱襯憲顧襯夢壓壓蓋膚 (積繭築艱鑰夢廠醖鏇憲 ) 更多	积极	2025-04-22
NCT06233591 (GlobeNewswire) 人工标引	临床2期	口腔扁平苔藓	-	LP-310	艱窪廠觸繭醖簾築廠積(願醖壓廠蓋網遞鏇衊糧) = The fact that LP-310 has been well tolerated so far, without unpleasant taste, is very encouraging. 願夢鑰範醖衊醖選廠繭 (齋鬱製糧衊膚襯顧製鹹 )	积极	2024-09-24